A man has filed a surgical infection lawsuit against the manufacturers of a cardiac heater-cooler device due to adverse effects and complications, including contraction of a serious infection.

Plaintiff Robert K. filed the surgical infection lawsuit in New York on March 8, 2018.

According to the surgical infection lawsuit, Robert filed his claims against defendant LivaNova PLC. He states that the cardiac heater-cooler device was used during his procedure to receive a coronary artery bypass at St. Joseph’s Hospital Health Center in Syracuse, N.Y.

The use of the device, however, led him to suffer serious and permanent injuries, the lawsuit states. He became diagnosed with a nontuberculous mycobacterium infection in August 2017.

According to the surgical infection lawsuit, he developed a Mycobacterium chimaera infection that caused him tremendous pain and impaired “nearly every aspect of the infected patient’s life,” the lawsuit states.

The surgical infection lawsuit was filed on multiple counts including design defect, failure to warn, manufacturing defect, breach of continuing duty to warn, breach of warranty, negligence, and violation of New York General Business Law.

Overview: Stockert 3T Heater Cooler Lawsuits

Numerous lawsuits have been filed against the makers of the Stockert 3T Heater Cooler system, LivaNova PLC (formerly known as Sorin Group Deutschland) over causing the development of a Mycobacterium chimaera infection.

The Stockert 3T system is one of the most popularly used devices during invasive surgeries.

The Stockert 3T serves a couple of purposes, which is why it has been so popularly used as with many kinds of heater-cooler devices. The purpose of the device is to maintain a patient’s body temperature at a safe degree during surgery, thereby keeping their organs safe and functioning. By keeping the body at a proper temperature, blood can continue to regulate properly to provide nutrients and oxygen to the body as needed.

Each year, 60 percent of open-heart surgeries are said to use heater cooler units, and there can be almost 250,000 such surgeries conducted each year.

The Stockert 3T system works by storing water in a tank, that can be kept at a specific temperature to cool down or heat up a patient’s body as needed. However, researchers say the tank can become contaminated and can aerosolize bacteria and infect a patient during surgery.

Once a patient has been infected with bacteria, it can also become very difficult to diagnose it, leaving even months or years to manifest. Some symptoms of an infection, however, can include night sweats; sudden weight loss; fatigue; muscle aches; and unexplained fever.

Warnings have previously been released by the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). A safety communication was released by the FDA in June 2016. They warned health care providers of the risks associated with heater cooler units and of warning about M. chimaera bacterial infection risks.

The announcement made by the FDA stated that they “received reports of U.S patients infected with M. chimaera after undergoing cardiothoracic surgery that involved the use of the 3T.”

According to the CDC, “in hospitals were at least one infection has been identified, the risk of a patient getting an infection from the bacteria was between about 1 in 100 in 1,000.”

The Surgical Infection Lawsuit is Case No. 5:18-cv-00301-GTS-TWD, in the U.S. District Court for the Northern District of New York.